MedDataX Logo

Adhesive Performance of Glass Ionomer and Resin Based Adhesive Systems: A 3 Years Prospective Clinical Evaluation

NCT ID: NCT05161559

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-30

Study Completion Date

2021-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aimed to clinically evaluate the 3-years clinical performance of glass ionomer and resin based adhesive systems in Class V restorations.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The formulated null hypothesis was that there is no significant difference in the clinical performances between glass ionomer and resin based adhesive systems in Class V restorations for 3-years.

The research question was as follows: Do glass ionomer adhesives in class V restorations present better clinical performances than resin based adhesive systems according to the modified United States Public Health Service (modified-USPHS) criteria?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dental Leakage

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Resin Composite Randomized Clinical Trial Operative Dentistry

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fuji Bond LC (Glass ionomer based adhesive)

Patients received in Class V cavity preparation Fuji Bond LC (Glass ionomer based adhesive) on one tooth of the mouth

Group Type EXPERIMENTAL

Chemical bond adhesive (GC, Corporation, Tokyo, Japan)

Intervention Type PROCEDURE

Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Riva Bond LC (Glass ionomer based adhesive)

Patients received in Class V cavity preparation Riva Bond LC (Glass ionomer based adhesive) on one tooth of the mouth

Group Type EXPERIMENTAL

Chemical bond adhesive (GC, Corporation, Tokyo, Japan)

Intervention Type PROCEDURE

Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Single Bond Universal (self-etch adhesive)

Patients received in Class V cavity preparation Single Bond Universal (self-etch adhesive) on one tooth of the mouth

Group Type EXPERIMENTAL

Self-etch adhesive (Kuraray, Tokyo, Japan)

Intervention Type PROCEDURE

No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)

Clearfill S3 Bond (self-etch adhesive)

Patients received in Class V cavity preparation Clearfill S3 Bond (self-etch adhesive) on one tooth of the mouth

Group Type EXPERIMENTAL

Self-etch adhesive (Kuraray, Tokyo, Japan)

Intervention Type PROCEDURE

No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)

OptiBond FL (three step etch & rinse adhesive)

Patients received in Class V cavity preparation OptiBond FL (three step etch \& rinse adhesive) on one tooth of the mouth

Group Type EXPERIMENTAL

Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Intervention Type PROCEDURE

Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etching with phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Etching enamel surface using phosphoric acid gel (3M ESPE, St. Paul, MN, USA)

Intervention Type PROCEDURE

Self-etch adhesive (Kuraray, Tokyo, Japan)

No Etching enamel surface using phosphoric acid (self-etch technique) (Kuraray, Tokyo, Japan)

Intervention Type PROCEDURE

Chemical bond adhesive (GC, Corporation, Tokyo, Japan)

Chemical bond with hydroxyapatite crystals of Enamel (GC, Corporation, Tokyo, Japan)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with primary caries involving cervical surface only with ICDAS 2 and 3.
2. Patients with normal and full occlusion.
3. Patients with tooth gives positive response to testing with an electric pulp tester.
4. Patients must have a good oral hygiene.
5. Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria

1. High caries risk patients with extremely poor oral hygiene.
2. Patients involved in orthodontic treatment or periodontal surgery.
3. Patients with periodontally involved teeth (chronic periodontitis).
4. Patients with heavy bruxism habits and clenching.
5. Patients with abutments should be excluded.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A12151221

Identifier Type: -

Identifier Source: org_study_id